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SafERteens M-Coach

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ClinicalTrials.gov Identifier: NCT03344666
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Maureen A Walton, University of Michigan

Brief Summary:
This study will use a SMART (Sequential, Multiple Assignment Randomized Trial) design to optimize adaptive interventions (AIs) for adolescents reporting alcohol misuse and violent behaviors. The study will test the efficacy of state-of-the-art adaptive intervention delivery approaches (text messaging, remote therapy) for reducing alcohol use and violent behaviors among urban teens. Given the morbidly/mortality associated with alcohol use and violence, this study will have significant impact by using a SMART design to identify the optimal intervention strategy to produce and sustain outcomes among at-risk youth.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Violence Behavioral: Step 1 Treatment BI+HC Behavioral: Step 1 Treatment BI+TM Behavioral: Step 2 Treatment Responders Behavioral: Step 2 Treatment Non-Responders Not Applicable

Detailed Description:
The specific aims are to: 1) Compare the efficacy of adaptive interventions (AIs) that begin with BI+TM (brief intervention + text messaging) vs. BI+HC (brief intervention + remote health coach) on reducing alcohol misuse and violent behaviors among youth while in the Emergency Department (ED); and, 2) Identify the most efficacious second-stage strategy post-ED visit for those who initially respond and for those who do not. Specifically, 700 youth (ages 14-20) in the ED screening positive for alcohol use and violent behaviors will be randomly assigned to: BI+TM or BI+HC. After receiving the SafERteens BI in the ED, youth will complete weekly assessments over an 8 week period to tailor intervention content and measure mechanisms of change, with one month determination of participant response (e.g., binge drinking, violence). Responders in each arm will be re-randomized to continued condition (e.g., stay the course or maintenance), or reduced condition (e.g., stepped down). Non-responders will be re-randomized to continued condition (e.g., stay the course or maintenance), or intensified condition (e.g., stepped up). Follow-up assessments will take place at 4 and 8 months post-baseline.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adaptive Interventions to Reduce Risky Drinking and Violent Behaviors Among Adolescents
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: First Treatment
Participants will be randomized to first treatment to compare Brief Intervention + Health Coach (Step 1 Treatment BI+HC) to Brief Intervention + Text Messages (Step 1 Treatment BI+TM). Participants in the BI+HC will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks. Participants in the BI+TM will receive a BI in the ED, followed by daily TMs for 4 weeks.
Behavioral: Step 1 Treatment BI+HC
Participants in the Brief intervention + Health Coach (BI+HC) will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks, which will occur by phone or in person. During sessions, the HC will review the prior week's progress, and discuss goals and plans for the following week.

Behavioral: Step 1 Treatment BI+TM
Participants in the Brief intervention + Text messages (BI+TM) will receive a BI in the ED, followed by daily TMs for 4 weeks. TM's are tailored based on weekly surveys and focus on motives for alcohol and violence and strategies to reduce involvement.

Experimental: Second Treatment for Responders and Non-Responders

Beginning in week 5, all participants will be classified as Responders or Non-Responders (based on weekly assessments) and re-randomized.

Step 2 Treatment Responders: Responders will be randomized to either stay the course or be stepped down. Specifically, participants in the BI+HC will either continue to receive the HC or stepped down to receive a control brochure; participants in the BI+TM will either continue to receive the TM or stepped down to receive a control brochure.

Step 2 Treatment Non-Responders: Non-Responders will be randomized to either stay the course or be stepped up. Specifically, participants in the BI+HC will either continue to receive the HC or stepped up to receive a HC+; participants in the BI+TM will either continue to receive the TM or stepped up to receive HC.

Behavioral: Step 2 Treatment Responders

Participants in the BI+HC assigned to stay the course (e.g., continue to receive the HC) will have 4 more weekly sessions with the HC.

Participants in the BI+TM assigned to stay the course (e.g., continue to receive the TM) will receive 4 more weeks of TM.

Participants in the BI+HC or BI+TM assigned to stepped down control will receive a brochure containing community resources.


Behavioral: Step 2 Treatment Non-Responders

Participants in the BI+HC assigned to be stepped up will receive HC+, which will consist of weekly sessions as well as on daily TMs from the HC.

Participants in the BI+HC assigned to stay the course (e.g., continue to receive the HC) will have 4 more weekly sessions with the HC.

Participants in the BI+TM assigned to be stepped up will receive the HC, which consists of 4 weekly sessions with the HC.

Participants in the BI+TM assigned to stay the course (e.g., continue to receive the TM) will receive 4 more weeks of TM.





Primary Outcome Measures :
  1. Change in Alcohol Consumption [ Time Frame: 4 months and 8 months post baseline ]
    Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including binge drinking, with total consumption calculated.

  2. Change in Physical Violence [ Time Frame: 4 months and 8 months post baseline ]
    Physical violence will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and severity of violent behaviors (e.g. push, shove, slap, kick, punch, weapon/firearm use or carriage etc.), with total violence calculated weighted by severity.


Secondary Outcome Measures :
  1. Change in Alcohol Consequences [ Time Frame: 4 months and 8 months post baseline ]

    Alcohol related consequences will be measured using the Young Adult Alcohol Consequences Questionnaire (YAACQ). This study will use a 24-item scale with the following responses (and values):

    0 = None

    1. = 1-2 times
    2. = 3-5 times
    3. = More than 5 times

    The responses will be summed for a total score.


  2. Change in Violence Consequences [ Time Frame: 4 months and 8 months post baseline ]

    Violence related consequences will be assessed using 13 items with following responses (and values):

    0 = None

    1. = 1-2 times
    2. = 3-5 times
    3. = More than 5 times

    These items will assess consequences such as injury, arrest, trouble at school or work, arguments or trouble getting along with friends and/or family members, feeling guilty, unable to stop/desire to fight, and worry or revenge as a result of participant's fighting. Responses are summed to create a total score.




Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients age 14-20 years presenting to the HMC ED for any reason(except exclusions as noted below)
  • past 4 month binge alcohol use and violent behaviors (i.e., physical aggression)
  • have a cell phone with texting capabilities and a cell phone plan for texting

Exclusion Criteria:

  • patients who do not understand English
  • patients deemed unable to provide informed consent due to mental incompetence, incarceration, or medically unstable (abnormal vital signs requiring urgent resuscitation) or
  • present for acute suicidal ideation or acute suicide attempt, child abuse, or sexual assault

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344666


Contacts
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Contact: Carrie Bourque, MS (734) 232-0406 csmolens@med.umich.edu

Locations
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United States, Michigan
University of Michigan Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Hurley Medical Center - Emergency Department Recruiting
Flint, Michigan, United States, 48503
Contact: Carrie Bourque, MS    734-232-0406    csmolens@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Maureen A Walton, MPH, PhD University of Michigan

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Responsible Party: Maureen A Walton, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03344666     History of Changes
Other Study ID Numbers: HUM00109156
R01AA024755 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior